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New treatment option for Atrial Fibrillation
Official title Use of 4D-ICE in Conjunction With TEE for Left Atrial Appendage Closure
ClinicalTrials.gov ID: NCT06061757
What this study is testing
- What it's testing
- This is a prospective, single center, non-randomized study with two parallel arms intended to study if 4D Intracardiac echocardiography (4D-ICE) (Nuvision, Nuvera TM) will provide better visualization of the anatomical landmarks from the larger imaging volume and provide optimal intra procedural guidance similar to Transesophageal echocardiography (TEE) (GE 6VT-D ULTRASOUND TRANSDUCER) for Left atrial appendage closure (LAAC). The study will enroll approximately 52 subjects and will be followed through 12 months.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Male/Females
- Age:18-80 years
- History of Atrial Fibrillation/Atrial flutter
- Will have endocardial Left Atrial Appendage Closure (LAAC) with an Amplatzer Amulet or WATCHMAN FLX device
You likely can't join if
- Inability or unwillingness of an individual to give written informed consent
- Patient not following with our practice after the procedure
- Complex anatomy for endocardial LAAC
- Thrombus in LAA
- Patients with pericardial effusion in pre-op TEE/CCTA
- Patients currently pregnant (Serum beta HCG completed when labs obtained for the procedure are completed)
The study team makes the final eligibility decision.
Where it's taking place
- Overland Park, Kansas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Overland Park, Kansas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.